Trial · NCT04166604
LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy
NCT04166604, Phase 2, Active not recruiting, GERCOR - Multidisciplinary Oncology Cooperative Group
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy. Trials, record NCT04166604. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04166604
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy
- NCT number
- NCT04166604
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 176 participants, actual
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Trifluridine/Tipiracil
- First posted
- 2019-11-18
- Last updated
- 2025-08-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of > 7 days at 6 months or at progression or death or stop of treatment for another cause than neutropenia if observed in 6 months. | At 6 months | To assess, in mCRC patients treated with trifluridine/tipiracil after the introduction of G-CSF in a secondary prevention attempt, the rate of patients free of trifluridine/tipiracil dose reduction or postponement of cycles of \> 7 days at 6 months from G-CSF first intake date or at progression or death or stop of treatment for another cause than neutropenia if observed in the 6 months. |
| Secondary | Overall survival (OS) | Up to 30 months | OS - defined as the time from study enrollment to death (from any cause) or to the last date the patients was known to be alive |
| Secondary | Progression free survival (PFS) | Up to 30 months | PFS - defined as the time (in months) from study enrollment until objective PD or death from any cause. If the patient dies before reaching PD, the date of death is considered as the date that PD was reached. For patients that had not reached PD at the time of the analysis, and for patients for whom the PD date is unknown, PFS is censored at the date of patient's final assessment prior to data cut-off. |
| Secondary | Objective response rate (ORR) | Up to 30 months | ORR - defined as proportion of patients with reduction in tumor burden of predefined amount. It refers to the number of patients with CR, PR according to RECIST v1.1 |
| Secondary | Disease control rate (DCR) | Up to 30 months | The disease control rate (DCR) is defined as the proportion of patients in whom the best overall response is determined as complete response, partial response or stable disease |
| Secondary | Safety descriptive analysis | Up to 30 months | Patients will be assessed for AEs throughout the study at every visit during treatment. Investigators using the NCI-CTCAE version 5.0 will grade the severity of AEs. |
| Secondary | The rate of dose reductions | Up to 30 months | Number of patients for whom a dose reduction was required and the reasons for dose reduction, |
| Secondary | Clinical or biological factors at baseline associated with the occurrence of grade 3-4 neutropenia | Up to 30 months | Identification of clinical and biological factors at baseline associated with the occurrence of grade 3-4 neutropenia in the whole cohort and design of predictive model of neutropenia occurrence |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04166604
GET https://conductscience.org/api/trials/v1/NCT04166604/registered